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The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fustion using autograft in skeletally mature patients in the following acute and chronic instabilities or deformities:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• . Spondy lolisthesis;
• Trauma (i.e. fracture or dislocation); -
• Spinal stenosis: -
• . Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor; •
• Pseudoarthrosis; and
• Failed previous fusion .

The Ø5.5mm rods from the Stryker Spinal System and Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System."

When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Stryker Spine XIA® 3 Spinal System is a noncervical pedicle screw system comprised of monoaxial and polyaxial bone screws, blocking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, CP Ti, and CoCrMo alloy (Vitallium).

Here's an analysis of the provided text regarding the acceptance criteria and study for the XIA® 3 Spinal System:

The provided document is a 510(k) Summary for the Stryker Spine XIA® 3 Spinal System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics. Therefore, the information you're asking for, particularly quantitative acceptance criteria and detailed study designs involving human readers or standalone algorithm performance, is not present in this document.

Instead, the document focuses on:

• Indications for Use: What the device is intended to treat.
• Device Description: What the device is made of and its components.
• Predicate Devices: Other similar devices already on the market.
• Substantial Equivalence Justification: How the new device is similar to the predicates.

Let's break down what is available and what is not:

Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with corresponding device performance metrics in the way one would expect from a performance study demonstrating efficacy (e.g., sensitivity, specificity, accuracy for a diagnostic device, or a specific functional outcome for a therapeutic device).

Instead, the "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to predicate devices. The performance is reported in terms of mechanical testing results that show compliance with established ASTM standards.

Missing Information (Not found in the provided document):

The following specific information about a study to prove the device meets acceptance criteria, particularly in the context of AI or diagnostic performance, is not present in this 510(k) submission:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for a performance study is described. The "testing" refers to mechanical integrity and engineering analysis.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is a spinal implant for mechanical fixation, not a diagnostic device requiring expert consensus on ground truth.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a diagnostic or AI device. The ground truth for this device's performance would be successful mechanical integration and stability within the human body, which is assessed through long-term clinical outcomes (not detailed here, but likely referenced in the clinical literature analysis) and through pre-clinical mechanical testing standards.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

Summary:

The provided document is a 510(k) summary for a spinal implant system (XIA® 3 Spinal System). The goal of this submission is to demonstrate substantial equivalence to already cleared devices, not to establish novel safety and effectiveness through new clinical trials with detailed performance metrics characteristic of diagnostic or AI-driven devices.

The "study" that proves the device meets (implicit) acceptance criteria consists of:

• Mechanical testing: Static and dynamic compression bending, static torsion (per ASTM F1717-04), and interconnection strength (per ASTM F1798-97).
• Engineering analyses: Dimensional comparisons to predicate devices.
• Clinical literature analysis: To support the intended use and safety/effectiveness history of similar devices.

Therefore, the specific types of questions relating to AI performance, reader studies, ground truth establishment, and training/test sets are not relevant to this particular 510(k) submission for a mechanical spinal implant and are consequently not answered within the provided text.

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